1. Field of the Invention
The present invention relates to packages for surgical instruments and devices, and more particularly to moisture impervious packages for surgical devices such as suture-needle assemblies which may be packed in a conditioning fluid medium.
2. Discussion of the Prior Art
Packages constructed of moisture impervious materials for surgical instruments and elements, such as surgical suture-needles and sutures in general, are well known in the art. These packages generally include a retaining member for holding the surgical elements in place within the package. The retainer is completely enclosed and sealed within the package to maintain sterility and prevent contamination of the surgical elements.
Packages constructed of moisture impervious material for surgical elements such as sutures and suture-needle assemblies are generally sealed by means of a heat seal device which creates a peripheral heat seal about the outer edges of the package. The material of which these packages are constructed usually include metal foil such as aluminum backed in laminate form with a plastic material such that the plastic forms the interior surface of the package.
The package is generally formed from a first wall of material upon which the retaining device holding the sutures or suture-needle assemblies is placed. A second wall then overlays the retainer and first wall of material, and a weld seal is formed by applying heat and pressure about the peripheral edge to completely seal the package and form the pocket therebetween which houses the retainer and sutures. This construction however, makes opening the package difficult and handling of the sutures inconvenient since the package typically must be torn open to access the contents.
In an improved form of package the second wall may cover only a portion of the retainer and first wall, and a closure flap member is then positioned to cover the remainder of the retaining device and first wall, and to overlap the second wall. The flat heat seal is then formed about the periphery of the package to seal the first wall to the second wall and the closure flap, as well as to seal the closure flap to the second wall to completely seal the package. In this construction an adhesive layer is provided between the closure flap and the first and second walls so that the package may be peeled open without tearing, by pulling the closure flap. This "mid-peel" construction facilitates opening of the package and makes handling of the sutures easier.
Many sutures and suture-needle assemblies require moisture impervious packaging to prevent evaporation of the conditioning fluid medium in which these elements are packaged. For example, sutures constructed of a gut-type material or a collagen material typically are packaged in a conditioning medium such as alcohol to prevent the sutures from drying out and cracking. In order to eliminate the possibility of evaporation of the alcohol medium, moisture impervious packages are provided to seal the alcohol therein and prevent leakage. To this end, the heat seal which is formed about the periphery of the package must also be impervious to moisture and not be susceptible to cracking in order to prevent the leakage and evaporation of the alcohol medium.
The mid-peel package with the peelable closure flap provides distinct advantages over the conventional tearable foil packages and is preferred. Depending on how the manufacturing and assembly process is conducted, however, it has been found that the presence of an alcohol conditioning fluid may cause difficulties in assembling the package so that the package seal is not compromised. By way of example, if the conditioning fluid is added before the closure flap is sealed to either or both of the first or second walls it is possible that alcohol vapor from the conditioning fluid may interfere with or hinder the adhesive curing process. This may cause an inadequate seal, possibly due to microscopic cracks or fissures across the seal area, thereby allowing the alcohol conditioning fluid to leak or evaporate from the package over time, resulting in a stiff suture at the time of use.
The novel packaging device for surgical elements such as sutures and suture-needle assemblies of the present invention obviates the disadvantages encountered in the prior art tearable packages and provides an improved peelable package which substantially eliminates the possibility of leakage of a conditioning fluid medium through the peripheral seal about the edges of the package. Sutures and suture-needle assemblies packaged in the conditioning medium are preserved in the package of the present invention through the provision of a novel arrangement to prevent the leakage and evaporation of the conditioning fluid from the moisture impervious package.